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Analgesic ANDAs

This article was originally published in The Tan Sheet

Executive Summary

Ohm Labs will launch acetaminophen 650 mg extended-release tablets (McNeil's Tylenol Arthritis Pain Extended Relief) in May, parent company Ranbaxy announces April 2. Ohm will have exclusive rights to market product under CorePharma ANDA (76-2000), approved by FDA March 19. CorePharma will manufacture the OTC. Also, Perrigo ANDA (75-995) for ibuprofen migraine pain 200 mg (McNeil's Motrin Migraine Pain) gets agency nod March 14. Private labeler's 1987 approval for ibuprofen 200 mg referenced Bristol-Myers Squibb's Nuprin, FDA says...
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